Abstract
The final text of the Trans-Pacific Partnership (TPP) is not yet officially available at the time of writing and so the exact contours of the deal are not yet known. However, there are reports that a complicated compromise has been agreed providing somewhere between five years and eight years data exclusivity. The TPP ministerial negotiating sessions include Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, USA and Vietnam. Data exclusivity refers to the period during which data submitted to regulatory agencies cannot be relied upon to evaluate marketing applications for generic products. The period commences from the marketing approval of the patented molecule and is separate to any patent rights. This is a significant barrier to entry as it requires the generic company to compile its own toxicology and clinical trial data which is very expensive and time consuming. The USA has been campaigning for 12 years exclusivity to ensure there would be an incentive for innovation while Australia and New Zealand have been campaigning for five years exclusivity to generate a greater access to cheaper biosimilar products. The USA Trade Representative has said this is the first ever trade deal in history which ensures a minimum period of protection for patented biologic medicines. Studies have shown that the TPP trade deal will raise the GDP of the 12 countries by $285billion or +0.9% by 2025. The TPP, if approved by each individual Government, will become the largest regional trade deal ever with its members accounting for nearly 40% of the world economy. Since there have been repeated failures to seal a global World Trade Organisation deal more countries are likely to consider joining the TPP such as Philippines, South Korea, Taiwan, Thailand and possibly China. However, any expansion of such data exclusivity provisions for biologic medicines will hinder the development of generic medicines for the poorer countries.
The public position on patents is simple enough: in return for registering an idea, which must be new, useful and non-obvious, a patentee will get a temporary monopoly. This is usually for 20 years and is designed as an incentive to innovate. However, what happens when these new patented medicines cannot be afforded by the middle classes in the USA, the national health services of Europe nor the poor of the developing countries? A re-examination of patents for medicines is overdue since the free market does not function in this sector. In addition, there is historical data that German and Italian pharmaceutical companies were more innovative before patent regimes were introduced than afterwards. As the disease load of developing countries moves closer each year to that of the developed countries, the need to find mechanisms that allow better access by developing countries to these expensive valuable patented medicines rises alongside the existing compulsory licence and voluntary licence legislation.
In this issue, we have a global portfolio of manuscripts including European packaging serialisation, the USA FDA, Iran and Malaysia.